Parallel Importing is where medicines and medical devices are imported from within the EEA into the UK, providing there is no difference to the UK product.
There are two different classifications of medicines that can be parallel imported – nationally authorised medicines and centrally authorised medicinal products.
Nationally authorised medicines are Parallel Imported and are authorised by the MHRA (Medicines and Healthcare products Regulatory Agency). The UK Parallel Importing scheme allows for a medicinal product authorised in another EU member state to be marketed in the UK providing there is no therapeutic difference from the UK product.
Centrally authorised medicinal products (CAPs) are Parallel Distributed and are checked by the EMA (European Medicines Agency). CAPs put on the market in one member state can be marketed in another member state by a distributor, independently of the marketing authorisation holder.
Medical devices do not need a marketing authorisation or licence to be parallel imported, but they are regulated by legislation and directives which need to be followed into order to import them into the UK.
Ardant Pharmaceuticals works closely with their partner Modus Consultancy for Parallel Imports. Modus manages all aspects of the parallel import licence process from initial application to ongoing maintenance, ensuring that licences are kept up-to-date and comply with the latest regulations, including the Falsified Medicines Directive (FMD).
Understandably, Brexit is creating an uncertain time as the pharmaceutical industry relies heavily on relations and regulations with the EU. In the event of a no-deal Brexit, Parallel Importing will change, but it will still continue. Parallel Importing has been one of the biggest driving forces for the industry in reducing costs, therefore there will always be a need and desire for Parallel Imports.